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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DII CONTROLLER; ARTHROSCOPE

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SMITH & NEPHEW, INC. DII CONTROLLER; ARTHROSCOPE Back to Search Results
Model Number 72200873
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference: case-(b)(4).
 
Event Description
It was reported that the dll controller was getting a "short circuit" message.The device was hot to the touch.Incident occurred while setting-up to a knee arthroscopy.A back-up device was available and no delays occurred.
 
Manufacturer Narrative
The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of "short circuit" error message was confirmed.Product failed functional testing with a short circuit error in port a only.The complaint was confirmed and the root cause has been determined to be a defective electronic component on the main pcb.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.Internal complaint reference: (b)(4).
 
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Brand Name
DII CONTROLLER
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
MDR Report Key11817306
MDR Text Key250369589
Report Number1643264-2021-01811
Device Sequence Number1
Product Code HRX
UDI-Device Identifier03596010607409
UDI-Public03596010607409
Combination Product (y/n)N
PMA/PMN Number
K062849
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number72200873
Device Catalogue Number72200873
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2021
Initial Date Manufacturer Received 04/21/2021
Initial Date FDA Received05/13/2021
Supplement Dates Manufacturer Received05/26/2021
Supplement Dates FDA Received05/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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